Tolerability of Goat Milk Protein in Eosinophilic Esophagitis Patients With Cow Milk Protein Trigger

NCT05180578 | Recruiting

• 1 other identifier: EoE tolerability of goat milk
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Eosinophilic esophagitis (EoE) is a chronic immune mediated disease characterized by eosinophilic infiltration in esophageal epithelium and resulting in esophageal dysfunction. While the exact pathogenesis is yet to be elucidated, EoE is considered an atopic disease. This classification is in part due to the inflammatory infiltrate of eosinophils, basophils and T-cells producing Th2 cytokines, yet it may also be triggered by environmental allergens. In addition, the rates of atopy are approximately 3 times higher in patients with EoE than in the general population. Furthermore, and most convincing, EoE is successfully managed with dietary exclusion of triggering groups in both pediatric and adult patients, further confirming the atopic nature of the disease. The most frequent dietary trigger for EoE is milk, but there is limited data on the cross-reactivity of milk from other species. Guidelines addressing the diagnosis and treatment of EoE in both children and adults have not addressed the use of non-bovine milk in patients with cow's milk triggered EoE. Restrictive diets are often challenging for patients and contribute to a reduced quality of life. Our own, anecdotal experience in two patients with milk triggered EoE who requested to introduce goat's milk into the patients' diet were that reintroduction did not trigger a clinical or histological flare of EoE. These cases of successful introduction of non-bovine milk introduces the possibility that a milk-free diet need not necessarily be exclusive of all species. The aim of this study is to assess tolerability and safety of goat's milk in patients with EoE in whom cow's milk has been confirmed to be a trigger food for their disease.

Conditions

Eosinophilic Esophagitis

Keywords

Eosinophilic Esophagitis; EOE

Outcome Measures

Primary Outcomes (1)

• Histologic remission rate following 12 weeks exposure to ingested goat's milk products

  will be assessed on biopsies collected at week 12 during upper endoscopy

  12 weeks exposure to ingested goat's milk products

Secondary Outcomes (4)

• Symptom scores following 12 weeks exposure to ingested goat's milk

  12 weeks exposure to ingested goat's milk

• Endoscopic remission rate following 12 weeks exposure to ingested goat's milk

  12 weeks exposure to ingested goat's milk

• Endoscopic improvement following 12 weeks exposure to ingested goat's milk

  12 weeks exposure to ingested goat's milk

• Safety of goat's milk challenge

  36 months

Study Arms (1)

Tolerability of goat milk consumption in patients with EOE triggered by milk allergy

EXPERIMENTAL

Elimination of cow milk from diet . Goat milk containing diet.

Other: Goat milk diet

Interventions

Goat milk diet OTHER

Elimination of cow milk from diet . Goat milk containing diet.

Tolerability of goat milk consumption in patients with EOE triggered by milk allergy

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Verified histologic remission on milk-free diet on endoscopy prior to intervention
• Proton-pump inhibitors may be used if treatment is maintained at the same dose from the screening endoscopy throughout the trial period, and was used at the time that milk was demonstrated to be the triggering food.
• Ability to consent to enrollment in the trial - legal guardians with joint consent for patients \>10 years.

You may not qualify if:

• Patients with clinical IgE-mediated milk allergy.
• Use of inhaled corticosteroids for more than 5 days per month during the trial period.

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek

Jerusalem, 91031, Israel

RECRUITING

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Oren Ledder, Dr.

CONTACT

+972-2-6666743; orenl@szmc.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Oren Ledder, Principal Investigator

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 6, 2022
• Study Start: November 12, 2020
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

IL (1)